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fda compliance check erp ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source :

Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirements needs, as well as product related components of environmental health and safety (EH&S).

Documents related to »fda compliance check erp

In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are turning to enterprise resource planning (ERP) solutions. Discover the five features any medical device manufacturer should look for in an ERP system in order to meet compliance requirements, produce high-quality products, operate efficiently, and maximize profitability.

fda compliance check erp 483 letter from the FDA can cause enormous harm to a company, in some cases leading to complete shut-down. The fact that these advanced software products are available and improving all the time is good news for medical device manufacturers. Plex Online is recognized as the No. 1 ERP solution for manufacturers*. Alone among the leading ERP solutions for medical device manufacturers, Plex Online provides all five of the features manufacturers must have in their ERP systems. Five Must-Have Features 1)
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To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

Midsize manufacturers and distributors now have access to an array of powerful software solutions that simply weren’t available before. But with so many choices, you need accurate and unbiased information. This comprehensive guide from TEC and SupplyChainBrain provides a state-of-the-market analysis, success stories from your peers, in-depth information on solutions, and a directory of the leading vendors in the field.

fda compliance check erp intense scrutiny by the FDA, the company faced new demands stemming from the Bioterrorism Act and the Customs Trade-Partnership Against Terrorism (CT-PAT) program as well as the enactment of the Sarbanes-Oxley Act. Many of the compliance activities were handled by manual processes with various spreadsheets, leading to insufficient controls with limited real time reporting. The company recognized the need to implement a new back office system, but the increasing demands placed on publicly-traded companies
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As your company grows, you must continually evaluate whether your work processes and IT solutions can solve your problems and help grow your business. By performing a gap analysis, you can look at where your business is headed and whether you have the right tools to get there. This white paper can help you perform a preliminary gap analysis to determine whether you need to upgrade your IT solutions and business processes.

fda compliance check erp following capabilities for meeting FDA demands? Does your system fully integrate all material planning processes and centrally capture traceability data? Does it support both forward traceability from ingredients to customer shipments and backward traceability from customer shipments to manufactured lots, and finally to ingredients or components received from suppliers? Does your system track lot properties, grades, and testing results? Does it include user-defined technical sheets and operational detail
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TEC is pleased to announce that NetSuite ERP is now TEC Certified for discrete manufacturing enterprise resource planning (ERP) under TEC’s ERP Evaluation Center. To obtain TEC certification, NetSuite completed TEC’s detailed research questionnaire and went through a formal, live demonstration of NetSuite ERP with TEC analysts.
NetSuite was founded in 1998 by Larry Ellison and Evan Goldberg and

Sage ERP X3 v.6 is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distribution in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

The trade-off between best-of-breed functionality and ease of integration is no longer so simple. Enterprise resource planning (ERP) software continues to expand, blurring the boundaries of core ERP functionality. The three essential factors to consider in ERP versus best-of-breed decisions are functionality, integration, and the ability to upgrade. Find out the questions you need to ask when considering an ERP extension.

Moving to the latest release of an enterprise resource planning (ERP) system is often perceived as a daunting task. But a new survey of enterprise system managers finds that most ERP upgrade efforts tend to be short in duration, fall within reasonable budgets, and rarely disrupt the business at large. Download this report for detailed survey results tracking enterprise application suite upgrade activity at respondents' businesses.

Infor ERP LN has a single code base for all platforms and supports integration with external systems, including the supply chain and the Web, using industry-standard technology. The solution supports processes from make-to-stock (MTS) to engineer-to-order (ETO), and cost-cutting techniques like flow line and lean manufacturing.
This cross-industry solution offers functionality for enterprises in discrete and project-based manufacturing industries, such as industrial machinery and equipment, high-tech and electronics, aerospace and defense, and automotive.
Infor Open Architecture, the service-oriented architecture on which Infor ERP LN is built, helps users create bridges with their supply chains through standards-based, loosely coupled integration (J2EE, SOAP, and WDSL) and complete support for Web services.

Until recently, enterprise resource planning (ERP) software was rarely considered for use in smaller firms, as core benefits—better business management via coordinated, standardized information and analysis—were often outweighed by costs and complexities of ERP systems. A variety of options have emerged to overcome concerns of the past. Read on the key considerations in an ERP decision and critical implementation factors.

Ramco Enterprise Process Manufacturing is TEC Certified for online evaluation enterprise resource planning (ERP) for process manufacturing solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, and in-depth analyst commentary.